Medicines containing testosterone carry a significant risk of venous thrombosis. The American health authority asks that it be specified on the instructions.
Prescription testosterone is not without risk… and patients should be warned. This June 20, the American drug safety authority (FDA) is asking for more details on the instructions. The risk of clot formation must be extended to all users, the agency establishes.
It is not uncommon to see a drop in testosterone in men over the age of 50. They may be prescribed testosterone, but this treatment carries significant risks. According to a study published in the JAMA, drugs increase the risk of cardiovascular events by 29% compared to men who do not take them. In early 2014, the FDA also launched a reassessment of the risks associated with taking testosterone. So far, the leaflets have only warned about the risk of venous thromboembolism (VTE) in men with an abnormal increase in the number of cells circulating in the blood (polycythemia). This is indeed one of the side effects of treatment with testosterone.
A risk of pulmonary embolism
Several cases of phlebitis related to taking testosterone, but not polycythemia, have been reported to the FDA. It therefore decides to extend the warning on adverse effects to all patients undergoing treatment. Because the formation of clots can lead to venous thrombosis or pulmonary embolism, which can lead to death. The FDA is also asking physicians to seriously consider the balance between the benefits and risks of such treatment before prescribing it. To be considered normal, the testosterone level must oscillate between 4 and 8 mg / ml of blood. This hormone, mainly produced by the testes, helps maintain bone density, the smooth distribution of fat and libido. Below this rate, there is a risk of osteoporosis and low libido. Despite everything, drug substitution should not be systematic, recalls the FDA.
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